This study will examine the utility of chitosan for reduction of blood or tissue levels of AGEs in patients with prostate cancer who are clinically stable on androgen-deprivation therapy.
The overall goal of this study is to identify a safe dose of the metabolic supplement, Chitosan that can help reduce AGE (advanced glycation endproducts) levels in patients with prostate cancer. Chitosan is a naturally occurring substance found in shellfish. This study will be using Chitosan prepared from the shells of cold-water shrimp. Chitosan is approved by the FDA for use in wound dressings and has been used in published clinical trials for weight loss but is not approved for the purposes of this study. AGEs are a type of metabolite, or substance, found in food and produced in the body. The researchers helping conduct this study have found a potential link between AGE levels and cancer. Participation in this study will require three study visits over the course of about 3 months. During these visits subjects will be asked to provide blood and stool samples as well as complete surveys about their quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Increasing dose levels from 500mg twice daily to 2000mg twice daily for up to 85 days.
Medical University of South Carolina
Charleston, South Carolina, United States
Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity
The maximum tolerated dose is defined as the dose that produces no more than 1 dose-limiting toxicity (DLT)in 6 subjects. Per protocol a DLT is defined as Grade 3 or higher hypophosphatemia and/ or Grade 3 or higher of any of the following toxicities, that the investigator deems related to chitosan, that do not improve or resolve within 7 days of onset: flatulence, increased stool bulkiness, bloating, nausea, heartburn
Time frame: 112 days
Change in Redox Status (RedoxSys, Serum Oxidized Glutathione)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days
Change in Inflammation (Plasma Cytokines, Toll-like Receptor Signaling)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days
Change in Insulin Resistance (HOMA-IR)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days
Changes in Bowel Permeability (Plasma Endotoxin)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days
Changes in Microbiome Diversity (16s rDNA Sequencing)
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days
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Correlate Changes in Serum AGE Levels (Pan-AGE, Carboxymethyllysine, Methylglyoxal
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days
Measure the Frequency of a > 30% Reduction in Total AGE Levels From the Pretreatment Level.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Time frame: 112 days